Contact information
Type
Scientific
Primary contact
Prof Anne Forster
ORCID ID
Contact details
Academic Unit of Elderly Care and Rehabilitation
Bradford Institute for Health Research
Temple Bank House
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
+44 (0)1274 383 406
a.forster@leeds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RP-PG-0606-1128
Study information
Scientific title
Stroke system of care trial: a cluster randomised trial evaluation of a patient and carer-centred system of Longer-Term Stroke Care
Acronym
LoTS Care
Study hypothesis
The hypothesis for LoTS Care is that a system of care delivered by a Stroke Care Co-ordinator (SCC) to patients and carers living at home, in the community, will improve psychological and functional outcomes compared to usual SCC practice.
The primary objective of the trial is to determine whether the system of care improves psychological outcomes for patients requiring long term care at home.
The secondary objectives include:
1. Improved functional outcomes for patients requiring long-term support at home
2. Improved psychological and functional outcomes for carers of patients requiring long term support at home
3. Cost effectiveness
Ethics approval
Leeds (West) Research Ethics Committee, 09/05/2008, ref: 08/H1307/43
Study design
Pragmatic multi-centre cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Community
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Stroke
Intervention
Stroke services will be randomised into intervention or control groups using the stratification factors of quality of the stroke unit; referral rate and SCCs working alone versus within a community multidisciplinary team.
SCCs in stroke services randomised to the intervention group will be trained to deliver a system of care centered on key problems identified as of central importance to stroke patients and their carers. The assessment schedule is presented in a manual comprising 16 questions (patient) and 11 questions (carer) representing the identified problem areas, linked to reference guides containing educational text with algorithms of evidence based treatment options and associated patient carer action plans. Implementation of the assessment system is supported by a specific training programme.
SCCs in stroke services randomised to the control group will continue to deliver current community-based practice as determined by local policy and practice.
The SCC will undertake a primary assessment of patients (and carer if appropriate) using the system of care and instigate service responses, with additional follow-up and monitoring visits as appropriate to the needs of individual patients. Therefore there are no specified treatment times for either arms. Follow up of both the control and intervention arms of the patients (and carers if applicable) will be followed up at 6 and 12 months.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
General Health Questionnaire 12 (GHQ12) completed by the patient 6 months after recruitment
Secondary outcome measures
The secondary outcome measures for patients at 6 and 12 months are:
1. Frenchay Activities Index
2. Barthel Index
3. EQ-5D
4. Stroke Impact Scale
5. Longer-term Unmet Need in Stroke
6. Satisfaction
7. Death
8. Hospital re-admission
9. Institutionalisation
10. Total costs
11. Cost-effectiveness/cost-utility
The GHQ12 at 12 months is also a patient secondary outcome measure to assess whether any intervention effect is sustained.
The secondary outcome measures for carers at 6 and 12 months are:
1. GHQ12
2. Carer Burden Scale
3. Satisfaction
4. Death
5. Institutionalisation
Overall trial start date
01/06/2008
Overall trial end date
30/04/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
The trial is evaluating a complex intervention delivered by the Stroke Care Co-ordinator (SCC) within a stroke service and eligibility criteria apply at three levels - the stroke service, the stroke unit and the SCC.
A stroke service will only be considered for inclusion in the trial if it includes a stroke unit which fulfils the Royal College of Physicians guidelines definition of a stroke unit, that is, by the presence of 4/5 of the following criteria:
1. Consultant physician with responsibility for stroke
2. Formal links with patient and carer organisations
3. Multidisciplinary meetings at least weekly to plan patient care
4. Provision of information to patients about stroke
5. Continuing education programmes for staff
Stroke Care Co-ordinators (SCC) will be eligible if they fulfill the following criteria:
1. A registered healthcare professional with documented experience in stroke care
2. Undertakes a community based liaison or co-ordinating role for stroke patients
3. Co-ordinates a range of longer-term care inputs on the patients' and carers' behalf (e.g., signposting, carrying out assessments)
4. Works within a stroke service as above
Patients with the following characteristics will be eligible for the trial:
1. Have a confirmed primary diagnosis of stroke
2. Are referred to a SCC on discharge home from hospital or within six weeks of stroke
3. Are still waiting for their first SCC assessment visit
4. Provide written informed consent or carer assent
All carers with the following characteristics are eligible for this study:
1. Identified by the patient
2. Eligible for this study
3. Provides the patient with practical support on at least a weekly basis
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
800 patients (and carers if applicable)
Participant exclusion criteria
Patients will be excluded from the trial if:
1. They are unlikely to survive for more than three months
2. Are being discharged to/resident in a nursing or residential home
3. Have been previously registered to the trial
4. They are taking part in other stroke research network adopted studies which involve 6- and 12-month follow-up questionnaires
Recruitment start date
01/06/2008
Recruitment end date
30/04/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bradford Institute for Health Research
Bradford
BD9 6RJ
United Kingdom
Sponsor information
Organisation
Bradford Teaching Hospitals NHS Foundation Trust (UK)
Sponsor details
c/o John Wright
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
+44 (0)1274 364279
j.wright@bradfordhospitals.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Funder name
Stroke Association
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25642527
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26152298